Neurocognitive Correlates of Behavioral Treatment for Chi... | NCT00675675

Studies
Neurocognitive Correlates of Behavioral Treatment for Childhood Tic Disorders

NCT00675675

Sponsor

John Piacentini

Status

Completed

Last Update Posted

Aug 21, 2015Estimated

Enrollment

53Actual

Phase

Not Applicable

Conditions

Tic Disorder

Interventions

Comprehensive Behavioral Intervention for Tics (CBIT)
Minimal Contact Waitlist

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
P50MH077248	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

May 7, 2008

First Submission Date that Met QC Criteria

May 9, 2008

First Posted Date

May 12, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 19, 2015

Last Update Posted Date

Aug 21, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study aims to clarify the functional anatomy of key brain circuits associated with cognitive control in children and adolescents with chronic tic disorders (CTD) and to compare and contrast hypothesized mechanisms related to increased tic control associated with Habit Reversal Training, a behavioral treatment that been previously shown to be effective in treating CTD. We also seek to better understand the relationship between fMRI and quantitative EEG in relevant brain circuits with the hope of establishing EEG as a valid and cost-effective marker of treatment responsiveness. A total of 25 subjects will be randomized to 10 weeks of Habit Reversal Training (HRT), a behavioral treatment, and 25 to 10 weeks of minimal-contact waitlist. Treatment responders will be re-assessed at three months. Waitlist nonresponders will be provided with 10 weeks of HRT. Study assessments, including a neurocognitive battery and quantitative EEG will be administered at baseline, Wk 5, Wk 10, and 3-month follow-up. Neuroimaging (fMRI) will be conducted at baseline and Wk 10.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Comprehensive Behavioral Intervention for Tics (CBIT)	Active Comparator	Habit Reversal Training (HRT) plus functional assessment/intervention designed to identify and ameliorate environmental triggers for and consequences to tics that might serve to maintain and/or generalize these symptoms	Behavioral: Comprehensive Behavioral Intervention for Tics (CBIT)
Minimal Contact Waitlist	Other	Bimonthly phone check-in to assess illness severity and maximize subject retention	Behavioral: Minimal Contact Waitlist

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Comprehensive Behavioral Intervention for Tics (CBIT)	Behavioral	Habit Reversal Training plus functional assessment/intervention designed to identify and ameliorate tic triggers (antecedents) and maintaining consequences.

Measure	Description	Time Frame
Clinical Global Impressions - Improvement		Wks 0, 5, 10

Measure	Description	Time Frame
Yale Global Tic Severity Scale		Wks 0, 5, 10

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

DSM-IV diagnostic criteria for CTD (CMVT or TS)
Clinical Global Impressions - Severity Score > 3 (moderately ill or worse)
YGTSS Total Score > 14 (or Total Score > 10 if CTD with motor tics only)
Unmedicated or on stable psychotropic medication for at least 6 weeks prior to study entry, with no planned changes for duration of study participation
Child is fluent English speaker
Parental Informed Consent and Child Informed Assent.

Exclusion Criteria:

Total YGTSS Score>35 (Cases above this threshold otherwise eligible will be reviewed by Clinical Caseness Panel for potential study participation)
IQ < 80 on the Wechsler Abbreviated Scale of Intelligence (WASI)
Problematic Substance Use or DSM-IV Conduct Disorder in past 3 months
Lifetime DSM-IV diagnosis of PDD, Mania, or Psychotic Disorder
Any serious psychiatric, psychosocial, or neurological condition requiring immediate treatment other than that provided in the current study
Previous treatment with four or more sessions of HRT for tics
Contraindication to fMRI scan

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

9 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Piacentini, Ph.D.	University of California, Los Angeles	Study Director
James McCracken, M.D.	University of California, Los Angeles	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of California, Los Angeles		Los Angeles	California	90024	United States

Condition Browse Module

MeSH Terms

ID	Term
D013981	Tic Disorders
D005879	Tourette Syndrome
D020323	Tics

Ancestor Terms

ID	Term
D009069	Movement Disorders
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D065886	Neurodevelopmental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided